Compliance Tech Writer Specialist

Compliance Tech Writer Specialist

SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto-injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018, with sites in Sweden, Taiwan, and the United States.

Job Overview

Provides periodic review of Facilities Department documentation and records such as logbooks and maintenance work records to assess for compliance with established quality standards, policies, and procedures. Participates in, and acquires results of, all Facilities Department quality and regulatory audits.

Main Responsibilities

• Manages and provides support, information, and assistance to the sitewide asset management system
• Acts as a liaison between the Facilities & Production Equipment Department and onsite quality and regulatory groups to define and address all issues of non-compliance
• Lead and participate in Facilities & Production Equipment Department issues of non-compliance to ensure all activities related to the investigation and resolutions of non-conformities are performed in a timely manner and in compliance with Regeneron procedures and regulatory requirements
• Facilitate reviews and revisions of Facilities & Production Equipment Department-related Standard Operating Procedures, Work Instructions, Risk Assessments, and OJT Task Evaluations for each group within the Department.
• Ensures written content meets all regulatory requirements and meets the SHL Medical Validation documentation standards other internal policies, procedures, and best practices
• Maintain a thorough knowledge of departmental policies, procedures, and contacts
• Ability to build strong relationships with key staff members and stakeholders
• Ensure timely and appropriate communication occurs with all client stakeholders
• Extensive self-study, training and testing are required
• Utilize a variety of tools including web portals, inline documentation, pdf documents, product walkthroughs
• Engage with necessary stakeholders to document procedures, policies, and reports in a standard, approved format
• Gathers, analyzes, translates, and composes technical information into clear, readable on-line information pages and documents to be used by technical and non-technical personnel
• Collaborate with individuals and groups with the initiation, review, submission, and follow-up of documents such as Change Controls and Corrective and Preventive Action plans, Validation and Commissioning documentation.
• Provides periodic review of Facilities & Production Equipment Department documentation and records such as logbooks and maintenance work records to assess for compliance with established quality standards, policies, and procedures.
• Participates in, and acquires results of, all Facilities / Production Equipment Department with quality and regulatory audits.
• Assist and take ownership of the facility change control program, deviation, events, and CAPA.
• Write Facility Department Investigations including Standard Operating Procedure, Change Control, Preventive Maintenance, Work Instruction, etc.
• Provides support and training for Facilities personnel on regulatory and quality topics, such as accurate documentation procedures and the use of QMS, SAP CR, CC
• Supporting the management of the regulatory communications process ensuring all regulatory communications/updates are received, summarized, cataloged, disseminated, and acted upon
• Other duties as assigned.

Skills and Qualification

• Bachelor’s degree in Engineering, Technical Communications, or any relevant field
• A minimum of 10 years experience in BioPharma or Medical Manufacturing is preferred.
• Excellent communication and interpersonal skills.  
• Strong knowledge of equipment and terminology used in the Biopharma and or medical field industry.
• Ability to work independently and make decisions with minimal supervision.
• Knowledge of relevant regulatory requirements, including FDA regulations and ISO standards.
• Supporting the management of the regulatory communications process ensuring all regulatory communications/updates are received, summarized, cataloged, disseminated, and acted upon

We Offer

• Competitive compensation package
• Modern working environment with state-of-the-art facilities and technologies
• Challenging assignments in a fast growing and innovative industry
• Position in a dynamic, international team of highly skilled professionals
• Various opportunities for personal and professional development within a global organization